Research Catalog
Development of FDA-regulated medical products : prescription drugs, biologics, and medical devices
- Title
- Development of FDA-regulated medical products : prescription drugs, biologics, and medical devices / Elaine Whitmore.
- Author
- Whitmore, Elaine.
- Publication
- Milwaukee, Wis. : ASQ Quality Press, [2004], ©2004.
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2 Items
| Status | Format | Access | Call Number | Item Location |
|---|---|---|---|---|
Not available - Please for assistance. | Text | Request in advance | RA401.5 .W48 2004 | Off-site |
Not available - Please for assistance. | Text | Use in library | Off-site |
Holdings
Details
- Description
- xx, 202 pages : illustrations; 24 cm
- Subject
- United States. Food and Drug Administration
- Drug approval > United States
- New products > Standards > United States
- Drug and Narcotic Control > legislation & jurisprudence
- Biological Factors
- Device Approval > legislation & jurisprudence
- Drug Approval > legislation & jurisprudence
- Government Regulation
- United States Government Agencies
- United States
- Note
- Previously published under the title: Product development planning for health care products regulated by the FDA.
- Bibliography (note)
- Includes bibliographical references and index.
- Contents
- Part I Unique Challenges in Medical Product Development -- Chapter 1 Healthcare in the United States 3 -- Chapter 2 It's Not Your Father's FDA: The "Modernization" of Medical Product Regulation 11 -- Chapter 3 Product Liability and Product Development 33 -- Part II Bringing a New Medical Product to Market -- Chapter 4 Overview of the Approval Processes for Drugs, Biologics, and Medical Devices 43 -- Chapter 5 Designing-in Quality 55 -- Chapter 6 Designing-Out Disaster: Risk Analysis 63 -- Chapter 7 Recalls, Revocations, and Withdrawals 71 -- Chapter 8 Human Factors and the Nature of Relationships: Minimizing Medical Errors 77 -- Chapter 9 Is It Safe and Does It Work? Evaluating Safety and Efficacy in Clinical Trials 87 -- Chapter 10 How Much Is the Product Really Worth? Outcomes Research, Pharmacoeconomics, and Managed Care 101 -- Part III Product Development Planning -- Chapter 11 Models and Metaphors: Product Development and the Product Development Organization 109 -- Chapter 12 Components of Product Development Planning: The Product Development Process 119 -- Chapter 13 Components of Product Development Planning: Development Portfolio Management 131 -- Chapter 14 Components of Product Development Planning: Technology Assessment 145 -- Chapter 15 Components of Product Development Planning: Technology Forecasting 153 -- Chapter 16 More for the Laundry List: Marketing, Patents, Budgets, Games, and Quality 163.
- ISBN
- 0873896130 (hbk. : alk. paper)
- 9780873896139 (hbk. : alk. paper)
- LCCN
- 2003023464
- OCLC
- ocm53331641
- 53331641
- SCSB-5778390
- Owning Institutions
- Columbia University Libraries